This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Aranesp® 10 micrograms solution for injection in pre-filled syringe
Aranesp® 15 micrograms solution for injection in pre-filled syringe
Aranesp® 20 micrograms solution for injection in pre-filled syringe
Aranesp® 30 micrograms solution for injection in pre-filled syringe
Aranesp® 40 micrograms solution for injection in pre-filled syringe
Aranesp® 50 micrograms solution for injection in pre-filled syringe
Aranesp® 60 micrograms solution for injection in pre-filled syringe
Aranesp® 80 micrograms solution for injection in pre-filled syringe
Aranesp® 100 micrograms solution for injection in pre-filled syringe
Aranesp® 130 micrograms solution for injection in pre-filled syringe
Aranesp® 150 micrograms solution for injection in pre-filled syringe
Aranesp® 300 micrograms solution for injection in pre-filled syringe
Aranesp® 500 micrograms solution for injection in pre-filled syringe
darbepoetin alfa
1. What Aranesp is and what is it used for 2. Before you use Aranesp 3. How to use Aranesp 4. Possible side effects 5. How to store Aranesp 6. Further information 7. Instructions for injecting with the Aranesp pre-filled syringe
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.
Please tell your doctor if you are suffering or have suffered from:
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Food and drink do not affect Aranesp.
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you:
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.
Aranesp should not affect your ability to drive or use machinery.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.
Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself.
For all adult and paediatric patients ≥ 11 years of age with chronic renal failure, Aranesp is given as a single injection, either once a week, once every two weeks, or once every month either under your skin (subcutaneous) or into a vein (intravenous).
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary.
Once your anaemia is corrected, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your anaemia. Your doctor will inform you if your dose changes.
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
In some cases, your doctor may recommend that you take iron supplements.
Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.
In order to correct your anaemia, your initial dose will be
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.
You could have serious problems if you take more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.
If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.
Like all medicines, Aranesp may cause side effects, although not everybody gets them.
The following side effects have been experienced by some patients taking Aranesp:
Chronic renal failure patients
Very Common (seen in more than 10 in 100 people)
Common (seen in more than 1 in 100 people)
Uncommon (seen in more than 1 in 1,000 people)
Frequency unknown
Cancer patients
Very common (seen in more than 10 in 100 people)
All patients
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Aranesp after the expiry date which is stated on the carton and on the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen.
Keep the pre-filled syringe in the outer carton in order to protect from light.
When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Do not use Aranesp if you notice the pre-filled syringe contents are cloudy or there are particles in it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.
Aranesp is available in packs of 1 or 4 pre-filled syringes. The syringes are provided either with (1- & 4-pack) or without (1-pack) a blister-wrapping. Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in December 2011.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
This section contains information on how to give yourself an injection of Aranesp. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
How do you or the person injecting you, use the Aranesp pre-filled syringe?
Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the skin. Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
Equipment:
To give yourself an injection you will need:
What should I do before I give myself a subcutaneous injection of Aranesp?
1. Remove the pre-filled syringe from the refrigerator. Leave the pre-filled syringe at room temperature for approximately 30 minutes. This will make the injection more comfortable. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Additionally, do not leave the syringe exposed to direct sunlight. 2. Do not shake the pre-filled syringe. 3. Do not remove the cover from the syringe until you are ready to inject. 4. Check that it is the correct dose that your doctor has prescribed. 5. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown. 6. Check the appearance of Aranesp. It must be a clear, colourless or slightly pearly liquid. If it is cloudy or there are particles in it, you must not use it. 7. Wash your hands thoroughly. 8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
How do I prepare my Aranesp injection?
Before you inject Aranesp you must do the following:
1. To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2. 2. Do not touch the needle or push the plunger. 3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless. 4. You can now use the pre-filled syringe.
Where should I give my injection?
The best places to inject yourself are the top of your thighs and the abdomen. If someone else is injecting for you, they can also use the back of your arms.
You may change the injection site if you notice the area is red or sore.
How do I give my injection?
1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger. 2. Insert the needle fully into the skin as shown by your doctor, nurse or pharmacist. 3. Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist. 4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty. 5. Remove the needle and let go of your skin. 6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster. 7. Only use each syringe for one injection. Do not use any Aranesp that is left in the syringe.
Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposing of used syringes
Link to this document from your website:http://www.medicines.ie/medicine/7762/XPIL/Aranesp+PFS/